Biostar Pharma Successively Achieved First Patient Dosing for Two Phase II/III Multiregional Clinical Trials of Utidelone Capsule (UTD2)

SAN FRANCISCO, Sept. 15, 2025 /PRNewswire/ -- Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. ("Biostar", Stock Code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that the first patients have been dosed for two phase II/III multiregional clinical trials (MRCT) of "Utidelone Capsule (UTD2) first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma" (NCT06841679) and "UTD2 treatment for platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer" (NCT07044349) on September 11, 2025 and September 12, 2025, respectively.

Utidelone has demonstrated excellent clinical data in gastric cancer: in a completed Phase II study of Utidelone Injection (UTD1) combined with PD-1 inhibitor and oxaliplatin for the first-line treatment of unresectable locally advanced or recurrent/metastatic HER2-negative gastric cancer, 23 patients had completed efficacy evaluation. Among them, 15 achieved partial response (PR) and 8 achieved stable disease (SD), resulting in a 65.2% objective response rate (ORR) and 100% clinical benefit rate (CBR). The median progression-free survival (mPFS) was 6.1 months. The combination regimen was generally well-tolerated. Most treatment-related adverse events (TRAEs) were Grade 1-2, reversible, and manageable. The longest treatment duration received by a patient was 22 cycles ^[1]. Consequently, Utidelone was granted an Orphan Drug Designation by the U.S. FDA for the treatment of advanced gastric cancer.

Besides gastric cancer, Utidelone has also shown considerable potential for treating ovarian cancer in previous clinical studies. A US Phase I clinical study of UTD2 as a monotherapy for advanced solid tumors had 12 evaluable patients, including one ovarian cancer patient with a complete response (CR) and another with PR, who had previously undergone 7 and 9 lines of therapy, respectively ^[2]. A Phase II clinical study of UTD1 as monotherapy for the treatment of advanced solid tumors had 10 evaluable patients in advanced ovarian cancer cohort, among them there were 1 PR and 3 SD.

Compared to taxanes, which are difficult for oral formulation development, Utidelone is not susceptible to P-glycoprotein thus cannot be pumped out of the cancer cell by P-glycoprotein and has the advantage for higher oral bioavailability and lower risk of developing cross-resistance. By utilizing its technology platform, Biostar developed Utidelone Capsule, and its efficacy and safety have been confirmed in both US and China's studies. Utidelone Capsule will significantly improve the convenience of administration, compliance of patients, decrease in treatment cost and ease of combination therapy with other oral anti-cancer drugs, and more suitable for adjuvant or maintenance therapy. Beyond gastric and ovarian cancers, Biostar is actively planning and advancing multiple clinical studies to expand UTD2's indications, including breast cancer adjuvant intensification therapy, pancreatic cancer, esophageal cancer, colorectal cancer, and so on.

About NCT06841679 Study

This study is a multi-national, open-label, randomized phase II/III clinical study of UTD2 combined with standard of care to evaluate the efficacy and safety in first-line patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, untreated with systemic treatment in the advanced setting. For the Phase II part, 78 subjects are planned to be enrolled in China, US, Europe and Japan. Its primary objectives are to evaluate the safety, efficacy, and pharmacokinetic profile of UTD2 in combination therapy. The Phase III part plans to enroll 700 subjects across multiple countries/regions. The primary endpoint is overall survival (OS), with secondary endpoints including PFS, ORR, and safety.

About NCT07044349 Study

This study is a multi-national, open-label, randomized Phase II/III clinical trial of UTD2 for the treatment of patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The Phase II part plans to enroll approximately 84 subjects. Its primary objective is to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of UTD2 under different dosing regimens in the target patient population and to recommend a dose for Phase III. The Phase III part plans to enroll 480 subjects and is planned to be conducted in multiple countries and regions worldwide. Its primary objective is to evaluate the efficacy and safety of UTD2 compared to the investigator's choice of standard treatment in the target patient population. The primary endpoint is PFS, with secondary endpoints including OS, ORR, and others.

About Utidelone

Utidelone is a new-generation genetically engineered microtubule inhibitor, and has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, better safety profile with very low hematologic toxicity, effective against multidrug-resistant tumors, less prone to developing drug resistance, capability of crossing the blood-brain barrier to prevent and treat brain tumors, and high oral bioavailability. Biostar has developed two formulations of Utidelone: injection (UTD1) and capsule (UTD2). UTD1 has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC), who have progressed after at least one anthracycline- or taxane-containing chemotherapy regimen. The phase III study data showed that UTD1 plus capecitabine achieved both PFS and OS benefits versus capecitabine for heavily pretreated MBC patients, and the results were orally presented twice at ASCO annual meetings and published in prestigious journals ^[3-4].

About Biostar

Biostar is an integrated biopharma company focusing on the development of innovative anti-cancer drugs utilizing its synthetic biology R&D platform. The company is listed on the Hong Kong Stock Exchange (HK 2563) in 2024. We are actively selecting reliable global partners through out-licensing or co-development of Utidelone assets. We believe that our strong capabilities of R&D and manufacturing, coupled with our enriched commercial expertise, make us the preferred partner for global biopharmaceutical companies who share our goal of bringing innovative anti-cancer products to patients around the world. For additional information on partnering with Biostar, please contact our business development team at [email protected].

Reference
[1] 2025 ASCO Abstract #: 4040
[2] 2025 ASCO Abstract #: 3030
[3] B. Xu, T. Sun, Q. Zhang, et al. Annals of Oncology, 2021, 32(2): 218-228
[4] Pin Zhang, Tao Sun, Qingyuan Zhang, et al. Lancet Oncol 2017; 18: 371-83

SOURCE Biostar Pharma, Inc.